Prof. Unguru Decries Drug Shortages

November 28, 2018

Calling access to essential medicines a basic human right, Berman Institute professor Yoram Unguru made a compelling argument for the United States Food & Drug Administration to establish an Essential Medicines List, as a first step in ensuring that the population has access at all times, and in sufficient amounts, to medicines that satisfy their priority health care needs.

Speaking at a Nov. 27 Washington, DC, meeting “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions,” convened in cooperation with the U.S. FDA, Dr. Unguru explained that shortages of vital drugs have harmed countless patients, been implicated in patient deaths between 2010-2012, and had a lasting detrimental impact on clinical research, threatening researchers’ ability to achieve meaningful progress in improving the lives of children with cancer.

“Typically, we only get one chance to cure children with cancer. If that opportunity is missed, it’s rare that we are able to cure them of their disease,” said Dr. Unguru.

“At the height of the shortages, a survey of medical oncologists found that a staggering 83% of oncologists weren’t able to prescribe their preferred chemotherapy agent. More than 75% had to make a major change in treatment such as choosing a different treatment regimen or substitute different drugs during the treatment. And over 40% had to delay the start of treatment. Two surveys of childhood cancer specialists, one in 2015 and again just last year, found the two out of three pediatric oncologists reported that their patients’ clinical care was compromised by the shortages.”

The purpose of the Nov. 27 meeting was to give stakeholders including health care providers, patients, manufacturers, wholesalers, pharmacists, pharmacy benefit managers, veterinarians, public and private insurers, academic researchers, and the public, the opportunity to provide input on the underlying systemic causes of drug shortages and to make recommendations for actions to prevent or mitigate drug shortages.

Dr. Unguru called on the FDA to join many other countries throughout the world in adopting the World Health Organization’s essential medicines list (EML). As defined by the WHO, essential medicines: “Satisfy the priority health care needs of the population. Medicines included in the EML are both clinically effective and cost effective and are to be available at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford.”

The current WHO Essential Medicines List for Children includes 18 chemotherapy agents and 4 supportive care medicines.

“This may shock you to hear, but over the past 2.5 years, nearly two-thirds of these essential medicines for children with cancer have been or are currently in short supply in the U.S. In fact, at this time, 5 of the 18 essential medicines, nearly 30%, are in short supply in the U.S.,” said Dr. Unguru.

Dr. Unguru is a pediatric hematologist/oncologist with joint faculty appointments at The Herman and Walter Samuelson Children’s Hospital at Sinai and The Johns Hopkins Berman Institute of Bioethics, where he is a Core Faculty member. He is also an Assistant Professor in the Johns Hopkins School of Medicine. Dr. Unguru is a member of the Children’s Oncology Group, and leads a multidisciplinary, transnational working group examining the ethical and policy implications of chemotherapy shortages in childhood cancer.

He has appeared, among other places, in the New York Times and on NPR to discuss allocation of scarce children’s cancer-treating drugs.

“Given the continued shortages of drugs, especially generic injectable drugs that are essential to the treatment of children with cancer, the United States should create an EML for pediatric oncology drugs,” Dr. Unguru said.

“Ultimately, what is needed is greater involvement by government. Congress must grant federal authorities the ability to ensure that patients in need have access to medications. Children with cancer should not have to continue to suffer because of inaction and a lack of will; they deserve better.”